Richard Wolf GmbH recalls PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables…

Recall date

April 9, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1753-2025

FDA classification

Class II

Brand / firm

Richard Wolf GmbH

Sold / distributed

US State: GA

Why it was recalled

The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).